Senior Director, Global Clinical Development; GI Oncology Princeton - NJ - US R160366

Position: Senior Director, Global Clinical Development (GI Oncology) Princeton - NJ - US + 2 more R160366[...]
## Senior Director, Global Clinical Development (GI Oncology)
Princeton - NJ - USFind out how well you match with this job
** Working with Us
** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more:
** The Senior Director, Global Clinical Development
** serves as the Clinical Indication Lead for one or more indications of a given asset.  This role is accountable for clinical strategy and execution in the given indication(s).  This role leads a team of physicians and scientists in the design, execution, analysis, and interpretation of all clinical studies for respective indications of a given asset.  
** Key Responsibilities
**** Clinical Strategy & Asset Leadership:
*** Owns and drives clinical development strategy across given asset indications, aligned to overall asset strategy, Target Product Profile (TPP), and relevant disease area strategy.
* May lead the Clinical Development Team(s) for given indication(s) depending on program structure
* Provides clinical and disease area expertise to integrated disease area and portfolio and therapeutic level strategies
* Represents Clinical as the internal and external authority for the indication/disease area, including regulatory interactions and Business Development support.
* Engages cross-functionally with internal leaders and partners with external investigators, key opinion leaders, and patient advocacy groups.
* Presents clinical strategy, data, and risk assessments to governance bodies, health authorities, and senior leadership.·        
** Clinical Study Design, Execution & Oversight
*** Leads a team of physicians and scientists in the design, execution, analysis, and interpretation of all clinical studies for given asset indication(s)
* Ensures studies meet regulatory, quality, medical, and access objectives and are aligned with target label indications.
* Ensures high quality, timely delivery of innovative protocols and data packages for CSRs and Regulatory Filings; implements quality assurance plans
* Accountable for clinical content and data quality for CSRs, trial documents, regulatory submissions, briefing books, and publications.
* Oversees trial progress, proactively identifies and mitigates risk, and provides regular status and risk updates to senior management.
* Champions quality, compliance, and GCP adherence across all clinical activities, partnering with Development Operations and Compliance as needed.
** Team Leadership & Talent Development
*** Sets priorities aligned to program objectives and works with Clinical Asset leadership to ensure appropriate budget/resourcing
* Attracts, develops, and retains top clinical talent through effective leadership, mentoring, and training.
* Fosters a culture of scientific excellence, collaboration, innovation, and accountability.
** Qualifications & Experience
*** Advanced degree in Life Sciences required (PhD, PharmD, MS, RN, MD or related field, MD)
* Deep clinical and therapeutic area expertise with advanced knowledge of drug development, competitive landscape, and health authority expectations.
* 8+ years of relevant experience, including leadership in the design and execution of multiple clinical trials.
* Demonstrated success in people leadership and/or matrix leadership roles.
* If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You…